This invention relates to the field of medical apparatuses. More particularly, the invention relates to a device for closure of an access site of a body vessel, such as a blood vessel.
Numerous advances of considerable note have occurred in medical surgical techniques over the last few decades. Among the most significant advances has been the adoption, and now-routine performance, of a variety of minimally invasive procedures. These minimally invasive procedures are distinguishable from conventional open surgical procedures in that access to a body vessel of a patient, such as a blood vessel, is achieved through a relatively small incision through the wall of the vessel. A tubular medical device (or tubular portion of a device) may be inserted or introduced through the incision into the interior space of the vessel for carrying out a medical procedure. The tubular device, or device portion, keeps the incision open while permitting access to the vessel via the interior passageway of the tubular device.
When carrying out such minimally invasive procedures, communication with the lumen of the vessel is typically attained by inserting an access device, such as an introducer sheath, through the opening in the vessel wall. One typical procedure for inserting the introducer sheath is the well-known Seldinger percutaneous entry technique. In the Seldinger technique, a needle is initially inserted into the vessel, and a wire guide is inserted into the vessel through a bore of the needle. The needle is withdrawn, and an introducer assembly is inserted over the wire guide into the vessel opening. Typically, the introducer assembly includes an outer introducer sheath, and an inner dilator having a tapered distal end. The tapered end of the dilator stretches the opening in the vessel in controlled fashion, so that introduction of the larger diameter introducer sheath may then be carried out with a minimum of trauma to the patient.
Following advancement of the introducer sheath into the opening, the dilator is removed, leaving at least the distal portion of the larger diameter introducer sheath in place in the vessel. The introducer sheath is generally provided with a valve at its proximal end for inhibiting leakage of body fluids through the introducer. A catheter may be inserted through the valve and the lumen of the introducer sheath. The catheter is threaded over the wire guide, and the distal end of the catheter is inserted into position in the vessel for carrying out the medical procedure. As a result, the introducer sheath can facilitate insertion of various devices into the vessel while minimizing trauma to the vessel wall and minimizing blood loss during the procedure. Upon completion of the medical procedure, the catheter and introducer sheath are generally removed, leaving a puncture at the vessel access site.
The puncture at the vessel access site is typically closed by suturing, or by manually providing pressure on the site until clotting and/or wound sealing occurs. Suturing is more often utilized for larger punctures, whereas manual pressure is more often utilized in connection with smaller punctures. The manual method, however, can take half an hour or more, and requires the patient to remain substantially immobilized for at least that period of time while pressure is applied by medical personnel to the access site. In addition, it may be necessary for the patient to remain in the hospital for a period of time thereafter for observation. Furthermore, there may be a possibility of clot formation at the puncture site.
Utilizing sutures and/or collagen plugs to close the opening may have procedure variability, which may require additional time to close the vessel. When sutures are utilized to close a larger vessel access site, they typically are of the “purse-string” type. In this type of suture, a single thread is stitched to surround the access site, and then pulled tight (like a purse-string) to close the access site. Performing this suture typically requires a good deal of skill and practice on the part of the physician. It also may be difficult to perform this type of suturing in a key-hole type procedure, or in other types of surgery where there is limited access to the wound site.
It is desired to provide a device for closure of a vessel access site that overcomes the problems of the prior art. It is also desired to provide a bioabsorbable device that need not be removed from the patient following closure of the vessel access site.